Medical device for modification of left atrial appendage and related systems and methods

• US 10,582,930 B2
• Filed: 06/12/2017
• Issued: 03/10/2020
• Est. Priority Date: 06/17/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Miles, Scott D., Davis, Clark C., Edmiston, Daryl R., Linder, Richard J., Martin, John Alexander
• Primary Examiner(s): Louis, Richard G
• Application Number:
  US15/619,798
• Publication Number:
  US 20170273690A1
• Time in Patent Office: 1,002 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/0069 with universal joint, cardan joint
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection

Abstract

Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device includes an occluder portion and an anchor portion, the anchor portion hingably coupled to the occluder portion. With this arrangement, the anchor portion actuates and pivots relative to the occluder portion between an anchor deployed position and an anchor non-deployed position while the occluder portion is in an occluder deployed position.

Claims

1. A method for modifying a left atrial appendage of a heart, the method comprising:

advancing a medical device with a catheter of a delivery system through a vasculature to the left atrial appendage of the heart in a constricted position, the medical device including a framework extending between a primary hub and a secondary hub each having a common axis;

deploying the medical device adjacent the left atrial appendage to a deployed position such that, in the deployed position, the framework extends radially outward from the primary hub to extend radially toward a distal side of the framework such that, at the distal side, the framework extends radially inward to the distal end of the framework and then turns proximally and radially inward toward the secondary hub, the secondary hub remaining proximal the distal end of the framework;

securing the medical device to tissue in the left atrial appendage with tissue anchors positioned on and extending from the framework proximal the distal end of the framework; and

releasing the catheter from the medical device to permanently leave the medical device in the left atrial appendage.

2. The method according to claim 1, wherein the deploying the medical device comprises deploying the medical device having a tissue growth member positioned at a proximal side of the framework.

3. The method according to claim 1, wherein the deploying the medical device comprises deploying the framework with multiple struts extending between a first end and a second end, the first end coupled to the primary hub and the second end coupled to the secondary hub.

4. The method according to claim 1, wherein the deploying the medical device comprises deploying an occluder portion of the medical device and separately deploying an anchor portion of the medical device.

5. The method according to claim 1, wherein the deploying the medical device comprises moving the secondary hub distally along the axis.

6. The method according to claim 1, wherein the deploying the medical device comprises actuating the secondary hub from a handle of the delivery system.

7. The method according to claim 1, wherein the deploying the medical device comprises moving a portion of the framework through a bore of the primary hub.

8. The method according to claim 1, further comprising retracting the tissue anchors from the tissue of the left atrial appendage subsequent to deploying the medical device.

9. The method according to claim 1, wherein the deploying the medical device comprises deploying the framework having a hingeable coupling along the framework between the primary hub and the secondary hub.

10. The method according to claim 1, wherein the deploying comprises deploying an occluder portion of the framework and separately deploying an anchor portion of the framework, the occluder portion including a tissue growth member attached thereto and the anchor portion hingeably coupled to the occluder portion.

11. A method for modifying a left atrial appendage of a heart, the method comprising:

advancing a medical device through a vasculature with a catheter to the left atrial appendage of the heart, the medical device having a framework extending between a primary hub and a secondary hub each having a common axis;

deploying the medical device in the left atrial appendage from a constricted position to a deployed position such that the secondary hub moves along the axis relative to the primary hub and such that, in the deployed position, the framework extends radially outward from the primary hub to extend radially toward a distal side of the framework such that, at the distal side, the framework extends radially inward to a distal end of the framework to then continue to extend radially inward and proximally toward the secondary hub such that the secondary hub remains proximal the distal end of the framework;

securing the medical device to tissue in the left atrial appendage with tissue anchors positioned on and extending from the framework proximal the distal end of the framework; and

withdrawing the catheter from the left atrial appendage and the vasculature with the medical device remaining secured to the tissue in the left atrial appendage of the heart.

12. The method according to claim 11, wherein the deploying the medical device comprises deploying the medical device having a polymeric member attached to a proximal side of the framework.

13. The method according to claim 11, wherein the deploying the medical device comprises deploying the framework with multiple struts extending between a first end and a second end, the first end coupled to the primary hub and the second end coupled to the secondary hub.

14. The method according to claim 11, wherein the deploying the medical device comprises deploying the medical device having an occluder portion and an anchor portion.

15. The method according to claim 11, wherein the deploying the medical device comprises moving the secondary hub distally along the axis.

16. The method according to claim 11, wherein the deploying the medical device comprises moving a portion of the framework through a bore of the primary hub.

17. The method according to claim 11, further comprising retracting the tissue anchors from the tissue of the left atrial appendage subsequent to deploying the medical device.

18. The method according to claim 11, wherein the deploying the medical device comprises deploying the framework having a hingeable coupling along the framework between the primary hub and the secondary hub.

19. The method according to claim 11, wherein the deploying comprises deploying an occluder portion of the framework and separately deploying an anchor portion of the framework, the occluder portion including a polymeric member attached thereto and the anchor portion hingeably coupled to the occluder portion.

20. The method according to claim 11, wherein the deploying the medical device comprises deploying the medical device having a porous member attached to a proximal side of the framework.